Clinical trial Recruiting at 1 site Observational Ages 18 to 46 Women only

Combining ovarian tissue freezing with egg (oocyte) freezing versus egg freezing alone

Official title: Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone: an Observational Study in Oncology Patients

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07546123 · Data updated 2026-11-12

This research will test whether combining ovarian tissue freezing with egg freezing helps adult women with cancer preserve more fertility than egg freezing alone.

Quick facts

Study typeObservational
Ages18 Years to 46 Years
SexWomen only
Enrollment127 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Bologna, Bologna)
StatusRecruiting
StartedAugust 25, 2025
Main results expectedJuly 2029
Study endsSeptember 2029
Registry record updatedApril 22, 2026
Trial IDNCT07546123 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–46 with an oncological diagnosis who are planning potentially gonadotoxic therapy, have BMI of 17.5–32, and have oncological clearance are ideal candidates.

Probably not a fit

Patients outside the age or BMI limits, those with active HBV/HCV/HIV or syphilis, those without oncological clearance, or those unable to undergo ovarian stimulation or surgery may not receive benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project will collect clinical data from two groups of adult oncology patients facing potentially gonadotoxic treatment: those who undergo ovarian tissue cryopreservation followed by oocyte cryopreservation, and those who undergo oocyte cryopreservation alone. Investigators will compare outcomes such as number of preserved follicles, number of mature oocytes retrieved, timing relative to cancer therapy, and recovery of ovarian endocrine function. Eligible participants are women aged 18–46 with BMI between 17.5 and 32 and oncological clearance, while patients positive for HBV, HCV, HIV, or Treponema pallidum or with hypersensitivity to stimulation drugs are excluded. The study is single-center and will use routine clinical and laboratory records at the treating hospital to characterize real-world differences between the approaches.

Why it matters

Potential benefit: If successful, the combined approach could preserve more follicles and mature eggs, increasing the chances of future pregnancy and helping restore ovarian hormonal function.

How similar studies have gone: Oocyte cryopreservation is well-established and ovarian tissue cryopreservation has led to restored ovarian function and live births in prior reports, but combining both approaches has limited published data.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patient with oncological disease eligible for potentially gonadotoxic therapy
* BMI ≥ 17.5 kg/m² and ≤ 32 kg/m²
* Age ≥ 18 years and ≤ 46 years

Exclusion Criteria:

* Hypersensitivity to one or more of the active substances used during ovarian stimulation treatment
* Positive for HBV, HCV, HIV, or Treponema pallidum
* Lack of oncological clearance

Where it's running

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, Bologna, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.